A prospective, randomized, controlled clinical study on the effectiveness of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of diabetic ulcers of the lower extremities.

Publisher: Blackwell Science Country of Publication: United States NLM ID: 9310939 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1524-475X (Electronic) Linking ISSN: 10671927 NLM ISO Abbreviation: Wound Repair Regen Subsets: MEDLINE

Publication: <2010-> : Malden, MA : Blackwell Science
Original Publication: St. Louis, MO : Mosby, c1993-

Diabetes Mellitus* ; Diabetic Foot*/therapy ; Negative-Pressure Wound Therapy* ; Varicose Ulcer*; Humans ; Lower Extremity ; Wound Healing

A multicenter, phase 4, randomized, comparative-efficacy study in subjects with lower extremity wounds was carried out to compare wound closure rates, for a single-use negative pressure wound therapy (s-NPWT) versus traditional NPWT (t-NPWT) systems over a 12-week treatment period. From the initial population of patients with diabetic foot ulcers (DFU) and venous leg ulcers (VLU), we analyzed a subgroup of patients with diabetes mellitus and leg and foot ulcers (either DFUs or VLUs in diabetics), termed, the diabetic lower extremity ulcers (DLEU). In the DLEU group, there were 95 patients in intention-to-treat (ITT) and 61 patients in per protocol (PP) populations, respectively. We found a significant difference in favor of s-NPWT over t-NPWT in the confirmed wound closures at 12 weeks both in ITT (p < 0.001) and PP populations (p = 0.017). Significantly higher wound closure rates in s-NPWT group suggest that s-NPWT should be preferred NPWT option for DLEU.
(© 2021 The Wound Healing Society.)

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Date Created: 20210915 Date Completed: 20220131 Latest Revision: 20220131

20231215

10.1111/wrr.12966

34525239